Wyniki wyszukiwania - BazTech

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Quality risk assessment and DoE – Practiced validated stability-indicating chromatographic method for quantification of Rivaroxaban in bulk and tablet dosage form

Palandurkar Kamlesh, Bhandre Richie, Boddu Sai H. S., Harde Minal, Lakade Sameer, Kandekar Ujjwala, Waghmare Prashant

Acta Chromatographica

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2023

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Vol. 35, no. 1

10--20

EN

A systematic DoE and Analytical Quality by Design (AQbD) approach was utilized for the development and validation of a novel stability indicating high-performance thin–layer chromatographic (HPTLC) method for Rivaroxaban (RBN) estimation in bulk and marketed formulation. A D-optimal design was used to screen the effect of solvents, volume of solvents, time from spotting to development and time for development to scanning. ANOVA results and Pareto chart revealed that toluene, methanol, water and saturation time had an impact on retention time. The critical method and material attributes were further screened by Box-Behnken design (BBD) to achieve optimal chromatographic condition. A stress degradation study was carried out and structure of major alkaline degradant was elaborated. According to the design space, a control strategy was used with toluene: methanol: water (6:2:2) and the saturation time was 15 min. A retention factor (RF) of 0.59 ± 0.05 was achieved for RBN using chromatographic plate precoated with silica gel at detection wavelength 282 nm with optimized conditions. The linear calibration curve was achieved in the concentration range of 200–1,200 ng/band with r2 > 0.998 suggesting good coordination between analyte concentration and peak areas. The quadratic model was demonstrated as the best fit model and no interaction was noted between CMAs. The optimized HPTLC method was validated critically as stated in International Conference on Harmonization (ICH) Q2 (R1) guideline and implemented successfully for stress degradation study of RBN. The developed HPTLC method obtained through AQbD application was potentially able to resolve all degradants of RBN achieved through forced degradation study. The obtained results demonstrate that a scientific AQbD approach implementation in HPTLC method development and stress degradation study drastically minimizes the number of trials in experiments, ultimately time and cost of analysis could be minimized.

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Stability study of tank containers placed on a roll-trailer during transportation by railway ferry

Fomin O., Vatulia G., Lovska A., Gerlici J., Kravchenko K.

TransNav : International Journal on Marine Navigation and Safety of Sea Transportation

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2021

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Vol. 15 No. 2

315--319

EN

The article presents the results of determining the dynamic load of the load-bearing structure of the tank container placed on a roll-trailer during transportation by railway ferry. For this purpose, a mathematical model was developed, which takes into account the dynamic loading of the tank container during angular displacements of the railway ferry. It is taken into account that the roll trailer is rigidly fixed on the deck, and the tank container and the liquid cargo in the boiler have their own degrees of freedom. The obtained accelerations are taken into account when calculating the stability of the tank container on the roll trailer. Thus the stability of the tank container is provided at lurch angles to 240. The carried-out researches will allow increasing safety of transportations of tank-containers on railway ferries by the sea, and also the efficiency of functioning of combined transportations in the international communication.

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Load carrying capacity numerical study of I-beam pillar structure with blast protective panel

Mazurkiewicz L., Kolodziejczyk D., Damaziak K., Malachowski J., Klasztorny M., Baranowski P.

Bulletin of the Polish Academy of Sciences. Technical Sciences

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2013

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Vol. 61, nr 2

451--457

EN

The paper presents numerical analyses aimed at preliminary assessment of the protective panel effectiveness, which task is to protect the elements of building structures against explosion. For the criterion of assessing the effectiveness of the panel the load capacity of the column made of steel I-beam was chosen. Ultimate force was determined by using advanced computational procedure, which consisted of four stages: preload, blast simulation, dynamic response and static analysis of deformed structure. Blast load was simulated using Lagrangian- Eulerian domain coupling. Results indicated that the application of the protective panel significantly reduces the plastic deformation of the structure.

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Stabilność paliw pozostałościowych i metody jej badania. Część II

Duda A., Łaczek T.

Nafta-Gaz

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2009

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R. 65, nr 7

556--560

PL

W niniejszym artykule opisano metody badania stabilności paliw pozostałościowych. Celem tych metod jest określenie tzw. stability reserve, czyli odporności na działanie niekorzystnych czynników, związanych z blendingiem paliwa z innymi frakcjami naftowymi, bądź wysoką temperaturą przechowywania produktu. Porównano wyniki badań stabilności uzyskane różnymi metodami.

EN

In the paper there were described methods for evaluating the stability of residual fuels. The aim of them is evaluating the stability reserve, i.e. the fuel resistance for the influence of the disadvantageous factors, like blending or storing in elevated temperature. There were compared the results obtained by different methods.